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Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Ms. Kraus is co-chair of the firm’s Health Care Industry practice group.
Ms. Kraus regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.
Ms. Kraus is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act ("HIPAA") and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.
Ms. Kraus' clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.
- Advising AstraZeneca on its global digital health partnership with BrightInsight for the development of digital health products and services (including Software as a Medical Device products).
- Assisted a major pharmaceutical manufacturer in conducting an internal audit of its price reporting function and determining the necessity for submitting restated price reports.
- Assisted a pharmaceutical company in obtaining Medicare Part D coverage for its previously excluded product.
- Assisted several pharmaceutical manufacturers in modifying their price reporting functions to comply with requirements imposed by the Deficit Reduction Act and the Affordable Care Act.
- Assisted numerous pharmaceutical manufacturers to ensure that their research activities conform to HIPAA and HITECH privacy requirements (for example, by conducting internal audits and by preparing investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements, service provider agreements, informed consents and authorizations).
- Assisted several device manufacturers to assess their status as business associates under HIPAA and HITECH and to develop appropriate compliance plans, policies and procedures.
Previous Experience
- U.S. Department of Health and Human Services, Deputy General Counsel (1993-2001)
March 2021
As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...
March 4, 2021, Inside Privacy
Two recent actions by lawmakers are intended to address certain uses of technology in health. First, two Senators have introduced a bipartisan bill related to the collection and use of identifiable health data from wearable health trackers. Second, following an appeal from Democratic lawmakers, the Agency for Healthcare Research and Quality (“AHRQ”) plans to ...
February 8, 2021, Covington Digital Health
The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information ...
February 8, 2021, Covington Digital Health
On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). OCR ordered the penalty in 2017... Continue Reading
February 1, 2021, Covington Digital Health
On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law. The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding ...
January 8, 2021, Covington Alert
For several years, mobile health and wellness applications (“digital health apps”) have grown in scale and popularity. A global pandemic in 2020 further accelerated the trend, with increased demand for remote monitoring and communication platforms, as well as new methods for wellness and disease prevention. In parallel, there were a number of important U.S. ...
December 21, 2020, Covington Digital Health
On December 10, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule to modify the Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”) promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health ...
December 21, 2020
WASHINGTON—Covington is assisting Veritas Capital-backed Gainwell Technologies in its acquisition of HMS for approximately $3.4 billion. The transaction is expected to close in the first half of 2021. Veritas will look to optimize the HMS solution set across Gainwell and Veritas-backed Cotiviti, Inc. Gainwell will acquire the HMS capabilities focused on the ...
December 17, 2020, Covington Alert
On December 10, 2020, the Supreme Court of the United States issued a decision in Rutledge v. Pharmaceutical Care Management Association holding that Arkansas’s Act 900, which regulates pharmacy benefit managers’ (“PBMs”) pharmacy reimbursement practices, is not pre-empted by the Employee Retirement Income Security Act of 1974 (“ERISA”). PBMs have long asserted ...
November 24, 2020, Covington Alert
On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) finalized two rules: (1) the “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” rule (the “AKS Final ...
November 23, 2020, Covington Alert
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule (“IFR”) implementing President Trump’s Most Favored Nation (“MFN”) executive order, which would tie Medicare Part B payments for certain drugs to the lowest price paid in other economically advanced countries (the “MFN IFR”). In a press conference on November ...
October 30, 2020
WASHINGTON—Covington represented GovernmentCIO, LLC, a leading provider of high-end technology and digital solutions to the Federal Health IT Services market, in its sale to Welsh, Carson, Anderson & Stowe. GovCIO is a rapidly growing provider of advanced technology solutions and digital services to the federal government. In the 10 years since its founding, ...
October 16, 2020, Covington Digital Health
California Attorney General Xavier Becerra (“AG”) announced in September a settlement against Glow, Inc., resolving allegations that the fertility app had “expose[d] millions of women’s personal and medical information.” In the complaint, the AG alleged violations of certain state consumer protection and privacy laws, stemming from privacy and security ...
HHS Announces Multiple HIPAA Settlements Related to Data Breaches and the Right of Access Initiative
October 6, 2020, Covington Digital Health
Throughout September, the Department of Health and Human Services, Office for Civil Rights (“OCR”), announced eight different settlements to resolve a variety of alleged violations of the Privacy and Security Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). Notably, three settlements stem from data breaches in ...
HHS Launches New “Health Apps” Website to Highlight HIPAA Guidance for Mobile Health Applications
September 16, 2020, Covington Digital Health
On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website. The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health Insurance Portability and Accountability ...
September 15, 2020, Covington Alert
The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders ...
July 23, 2020, Covington Digital Health
On July 13, 2020, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising the Confidentiality of Substance Use Disorder Patient Records regulations located at 42 C.F.R. Part 2, commonly referred to as “Part 2.” Under Part 2, federally assisted substance use disorder ...
May 15, 2020, Inside Privacy
On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”). The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and... Continue Reading…
May 15, 2020, Covington Digital Health
On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”). The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and... Continue Reading
May 15, 2020, Covington Alert
On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Final Rule”). The final rule, which will go into effect on July 13, 2020, expressly allows certain health plans to determine, to the extent permitted by state law, whether to count pharmaceutical ...
May 6, 2020, Covington Digital Health
On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020. This joint announcement was made by the Office of ...
CMS Announces New Flexibilities For Coverage of Medicare Part B Drugs Administered in a Home Setting
April 22, 2020, Covington Alert
On March 30, 2020, CMS announced that, in light of the coronavirus pandemic, it would be waiving several Medicare reimbursement regulations to permit reimbursement to providers treating patients remotely, consistent with current social distancing guidelines, and would be allowing providers to receive reimbursement for Medicare Part B drugs that are administered ...
April 20, 2020, Covington Alert
The Department of Health and Human Services (HHS) has released details relating to the disbursement of the first $30 billion of $100 billion in funding allocated by the CARES Act to the Public Health and Social Services Emergency Fund (PHSSEF). Pub. L. 116- 136, Div. B (Mar. 27, 2020). HHS began making payments to eligible providers on April 10, 2020.
April 3, 2020, Inside Privacy
On April 2, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding the disclosure of protected health information (“PHI”) to public health authorities and use of PHI to perform analytics for such authorities. Designed to “facilitate uses and disclosures for public health and ...
March 24, 2020, Inside Privacy
This month, the U.S. Department of Health and Human Services (“HHS”) issued guidance waiving enforcement of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) in response to the COVID-19 nationwide public health emergency. Covered Health Care Providers On March 17, 2020, the Department of Health and Human Services Office for ...
March 18, 2020, Covington Alert
To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind. For additional guidance, please visit our COVID-19 Legal and Business Toolkit or reach out to us at COVID19@cov.com.
Covington Assists Veritas Capital with $5 Billion Acquisition of DXC’s Health and Human Services Business
March 10, 2020
WASHINGTON—Covington is assisting Veritas Capital with its acquisition of DXC Technology’s U.S. State and Local Health and Human Services business in a deal valued at $5 billion. The transaction is expected to close no later than December 2020, subject to the satisfaction of customary closing conditions. DXC Technology’s U.S. State and Local Health and Human ...
February 26, 2020, Covington Alert
On January 27, Practice Fusion, Inc. (“Practice Fusion”), an electronic health record (“EHR”) company acquired by Allscripts in 2018, agreed to pay $145 million to resolve criminal and civil investigations with the Department of Justice (“DOJ”) related to an illegal kickback arrangement with a major opioid company. Practice Fusion solicited and received nearly ...
January 17, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited in itsdefinitive agreement to sell Decision Resources Group to Clarivate Analytics plc, in a deal valued at $950 million. The $950 million purchase price includes $900 million in cash and approximately $50 million in Clarivate ordinary shares to be issued following the one-year anniversary of ...
January 8, 2020, Covington Alert
On December 31, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a final rule updating the Medicaid Drug Rebate Program (“MDRP”) regulations to, among other things, facilitate value-based purchasing (“VBP”) arrangements for prescription drugs, expand the universe of drugs that would be considered line extensions, and ...
Health Care Cases To Watch In 2020
January 1, 2020, Law360
Anna Kraus spoke with Law360 about Texas v. U.S., a Republican-led challenge to the ACA's constitutionality. "Ultimately, the outcome of this case could affect almost everyone in the country.” She adds that the case is “by far the most important case to watch in 2020.”
January 2020
Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...
CMS Releases Final Hospital Price Transparency Rule and Proposes Transparency Rule for Health Plans
November 27, 2019, Covington Alert
On November 27, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a final rule and proposed rule that each aim to increase the transparency of hospital and insurer prices.
June 22, 2019, Inside Privacy
Last week, Senators Amy Klobuchar (D-MN) and Lisa Murkowski (R-AK) introduced the Protecting Personal Health Data Act (S. 1842), which would provide new privacy and security rules from the Department of Health and Human Services (“HHS”) for technologies that collect personal health data, such as wearable fitness trackers, social-media sites focused on health ...
February 6, 2019
NEW YORK—Covington has advised Sensyne Health, the British clinical AI technology company, on its agreement with Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States. GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of ...
February 1, 2019, Covington Alert
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a new rule yesterday proposing to revise the Anti-Kickback Statute safe harbor at 42 C.F.R. § 1001.952(h) to explicitly exclude manufacturer rebates and other price reductions on prescription drugs paid to Part D plans, Medicaid managed care organizations (MCOs), or ...
January 29, 2019, Inside Privacy
Hospitals and other health care organizations are attractive targets for cyber-attacks, in part because their databases contain medical records and other sensitive information. Breaches of this information could have very serious implications for patients. Moreover, electronics connected to a health care facility’s network keep people alive, distribute ...
November 12, 2018
WASHINGTON—Covington is advising private equity firm Veritas Capital on healthcare and other regulatory aspects of its recently announced deal to acquire athenahealth for approximately $5.7 billion. athenahealth is a leading provider of network-enabled services for hospital and ambulatory customers nationwide. Rujul Desai and Ian Brekke are leading the Covington ...
March 15, 2018, Covington Alert
On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs.
December 11, 2017, Covington Alert
On November 28, 2017, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule touching on a range of issues under the Prescription Drug Benefit (Part D) and Medicare Advantage (MA) programs, and implementing certain provisions of the Comprehensive Addiction and Recovery Act (CARA) and of the 21st Century Cures Act. 82 ...
October 11, 2017, Covington Alert
On Monday, October 9, 2017, California Governor Jerry Brown signed into law Senate Bill 17 (SB 17), establishing substantial new reporting and notification requirements in California for prescription drug manufacturers related to drug pricing. California is the latest of several states to enact legislation related to drug pricing. This alert, prepared by ...
March 13, 2017, Covington Alert
Last week, House Republicans introduced long-awaited legislation, through “budget reconciliation,” to “repeal and replace” the Affordable Care Act (ACA). The American Health Care Act (AHCA) makes major changes to current law.
January 24, 2017, Covington Alert
On January 20, 2017, President Donald J. Trump signed an Executive Order instructing federal agencies to work to “minimize the unwarranted economic and regulatory burdens” of the Affordable Care Act (“ACA”), and to increase the flexibility provided to States to run healthcare programs. (The text of the order can be found at the end of this advisory.) While the ...
June 30, 2016
On June 23, the Centers for Medicare & Medicaid Services (“CMS”) published its final rule to implement Medicare laboratory policy changes made under Section 216(a) of the Protecting Access to Medicare Act of 2014 (“PAMA”). Responding to public comments it received on last year’s proposed rule, CMS made a number of significant changes and postponed the PAMA ...
Covington Represents Underwriters in Senseonics' IPO
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
February 1, 2016, Covington Alert
CMS Issues Delayed Proposed Rule Implementing PAMA’s New Clinical Laboratory Reimbursement Criteria
October 7, 2015, Covington Alert
Moving to the Cloud: Privacy and Other Key Considerations for Healthcare Entities
May 13, 2015, Life Sciences Essentials Webinar Series
May 12, 2015, Inside Privacy
As we discussed in two prior posts (here and here), the April 29, 2015, draft House 21st Century Cures bill would make several changes to federal health privacy law. This post focuses on provisions that would relax limitations on payment for PHI disclosed for research purposes and that would expand the purposes for which covered... Continue Reading…
May 8, 2015, Inside Privacy
As we discussed in a prior post, the April 29, 2015, draft House 21st Century Cures bill would make several changes to federal health privacy law. This post focuses on provisions that would allow remote access to PHI for purposes preparatory to research and that would permit individuals to make a one-time authorization of the... Continue Reading…
May 6, 2015, Inside Privacy
On April 29, 2015, the U.S. House Energy and Commerce Committee released a revised discussion draft of the 21st Century Cures Act (“Cures”). The Cures bill would make several changes to existing federal privacy regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and ...
March 9, 2015, The National Law Journal
December 23, 2014, Covington E-Alert
October 27, 2014, Covington E-Alert
June 5, 2014, Covington E-Alert
March 25, 2014, Covington Advisory
11/07/2013
WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...
September 23, 2013, Inside Privacy
On September 19, HHS released additional guidance on the “refill reminder exception” in HIPAA, which allows — in some circumstances — paid communications regarding a drug or biologic currently prescribed to a patient. Background In January 2013, HHS finalized new restrictions on marketing as part of the final omnibus rule implementing changes to HIPAA under... ...
December 3, 2012, Inside Compensation
The U.S. Department of Health and Human Services (HHS) recently released guidance on methods for de-identification of protected health information (PHI) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The guidance, which was required under Section 13424(c) of the Health Information Technology for Economic and ...
June 29, 2012, Covington Advisory
June 15, 2012, Covington Advisory
Q&A With Covington's Anna Kraus
June 12, 2012, Law360
Anna Kraus participated in a Q&A.
May 7, 2012, Covington E-Alert
4/23/2012
NEW YORK, April 23, 2012 — Covington & Burling represented Thomson Reuters in a definitive agreement to sell its Healthcare business to an affiliate of Veritas Capital for $1.25 billion in cash. The sale, expected to close in the next few months, is subject to regulatory approval and customary closing conditions, including the expiration or termination of ...
February 23, 2012, Bloomberg Law Reports
CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act
February 10, 2012, Covington E-Alert
January 3, 2012, Covington E-Alert
December 30, 2011, Covington E-Alert
September 1, 2011, Covington E-Alert
June 2011, Bloomberg Health Law Report
July 26, 2010, Covington E-Alert
June 2010, Covington E-Alert
April 29, 2010, Covington E-Alert
April 2010, Covington E-Alert
April 2010, Covington E-Alert
November 6, 2009, Covington E-Alert
September 1, 2009, Covington E-Alert
June 19, 2009, Covington E-Alert
April 29, 2009, Covington E-Alert
March 20, 2009, Covington E-Alert
Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009
March 6, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
12/11/2008
WASHINGTON, DC, December 11, 2008 — Salix Pharmaceuticals, Ltd. announced that it has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Covington & Burling LLP represented Salix in the deal. Crofelemer currently is being investigated in a Phase 3 study as an anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV. Salix ...
December 1, 2008, Covington E-Alert
December 18, 2007
NEW YORK, NY, December 18, 2007 — BUPA today announced that it has entered into an agreement to acquire Health Dialog. Covington and Burling LLP represented BUPA, Health Dialog’s largest shareholder, in the $775M transaction, which is expected to close in January. BUPA is a global provider of healthcare services and is the largest private health insurer in the ...
August 7, 2007, Covington E-Alert
May 3, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
October 9, 2006, Covington E-Alert
August 24, 2006, Covington E-Alert
March 3, 2006, Covington E-Alert
April 5, 2005, Covington E-Alert
April 4, 2005, Covington E-Alert
February 1, 2005, Covington E-Alert
January 27, 2005, Covington E-Alert
December 2004, Covington E-Alert
December 2004, Covington E-Alert
December 2004, Covington E-Alert
September 17, 2004, Covington E-Alert
April 14, 2004, Covington E-Alert
December 11, 2003, Covington E-Alert
November 26, 2003, Covington E-Alert
- Legal 500 US, Media, Technology & Telecoms - Technology: Data Protection & Privacy (2013)
- Washington DC Super Lawyer, Health Care (2013-2015)
- LMG Life Sciences, “Life Science Star” (2012-2013)
COVID-19: Legal and Business Toolkit
We are helping clients around the world navigate this evolving, complex situation.
Practices
Education
Stanford Law School, J.D., 1982
- Order of the Coif
- Stanford Law Review, Managing Editor
Stanford University, M.B.A., 1982
- Arjay Miller Scholar
University of New Mexico, B.A., 1978
- summa cum laude
- Phi Beta Kappa